Diagnostics

Illumina inks deal with J&J, AstraZeneca, Sanofi

The goal is to develop companion diagnostics to match patients with cancer treatments.

Colorectal cancer test is FDA moment of sorts

Cologuard was the first approved fecal-based screening test for the disease, and it was also the first product the FDA and CMS approved on the very same day through the so-called Parallel Review program.

AZ seeks blood test to ID potential patients

AstraZeneca's hope is that the blood test could replace tissue samples and be used to identify patients who could benefit from its lung drugs.

J&J gets out of diagnostics

The Carlyle Group has picked up Johnson & Johnson's Ortho Diagnostics for $4B.

Covidien buys firm armed with missile tech

Covidien is buying ingestible-camera company Given Imaging.

ADHD rise spurs diagnostics firms

ADHD rise spurs diagnostics firms

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Research suggests ADHD is becoming a regular fixture in adolescence. At the same time, publishers and startups have developed increasingly complex tools to separate patients from abusers.

FDA slams 23andMe over genetic testing device

FDA slams 23andMe over genetic testing device

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Regulators say the company has not received approval for the device's touted functions.

FDA exempts most mobile apps from scrutiny

FDA exempts most mobile apps from scrutiny

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The agency issued final guidance on mobile apps, saying it will focus only on a subset that present the greatest risk to patients if they don't work correctly.

"Sensor you swallow" passes psych test

"Sensor you swallow" passes psych test

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Proteus Digital Health's ingestible sensor shows utility as an adherence tool for those on psych meds, a study suggests.

Genetic testing firm airs TV spot as part of $5M ad buy

Genetic testing firm airs TV spot as part of $5M ad buy

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23andMe aired its first TV ad Monday, in a bid to build the audience for DNA sequencing.

Business briefs: Lundbeck/Otsuka, Abbott, Merck

Lundbeck and Otsuka prime Alzheimer's med for Phase III trials; Abbott reports Q2 results; and an FDA panel shrugs off Merck's muscle relaxant for another day.

Amyvid tracer figures in Lilly's latest solanezumab trial

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The drug maker's third round of testing will focus on mild Alzheimer's patients. Candidates must test positive for beta amyloid.

Roche's bid to expand HPV test could edge out Pap

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The diagnostic firm is looking to expand its Cobas HPV diagnostic into first-line use, possibly edging out the older Pap test.

Business briefs: Roche and Digitas Health

Roche buys diagnostics firm, and a study shows women are major mHealth users; plus: librarians enlisted to help navigate healthcare reform.

Navidea deploying MSLs in launch of new diagnostic agent

Navidea deploying MSLs in launch of new diagnostic agent

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Medical science liaisons will educate nuclear-medicine clinicians as part of the launch of a new Navidea diagnostic agent for use in breast and skin cancer.

Studies show cost doesn't drive everything

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Two studies show that it's not enough to focus on cost to alter healthcare.

Company news: McCann, Millennium Research Group

Internet trends show fondness for online health information, but no need for docs to take on a third job, Millennium says diabetes device market to grow moderately over five years.

Company news: UBM Medica, Bayer

Publisher UBM spurs medical competition among psychiatrists, Bayer says it's keeping its diabetes division.

Company news: GlaxoSmithKline, Royal Philips

GSK, Pfizer and Shionogi's HIV medication to get its day in regulatory court; Philips finds that mobile and health are becoming inseparable.

Home HIV test maker preps TV ad fusillade, lures Pfizer marketer

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OraSure, the maker of the recently-approved home HIV test, has hired an experienced consumer marketer from Pfizer to head up the launch as it readies a TV ad campaign.

Company news: MedMira; FDA device ID

Diagnostics firm MedMira gets a contract from the US Army to develop a screening tool, and the FDA proposes some new device guidelines.

Post ASCO, talk turns to prepping BMS therapy for launch

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As the big cancer meeting wound down, talk turned to the best way to prepare Bristol-Myers Squibb's anti-PD-1 antibody, a potential blockbuster, for launch.

How CDC's hep.-C testing advice benefits drugmakers now

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The CDC's proposal that all US baby boomers get a one-time test for the hepatitis C virus has already given a boost to drugmakers in the antiviral space.

Endo rebrands to move beyond roots in pain drugs

Endo rebrands to move beyond roots in pain drugs

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Endo is restructuring, bringing its four operating units under the same corporate roof and rebranding to reflect its diversification out of its origins in pain and urology drugs.

Pfizer effort urges lung cancer patients to get gene tests

Pfizer effort urges lung cancer patients to get gene tests

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Pfizer Oncology has recruited Desperate Housewives and West Wing star Kathryn Joosten to feature in a national education campaign titled Lung Cancer Profiles, which aims to reduce stigma and plug molecular testing of the disease as the company deepens its investment in genetically-targeted oncology therapies.

Quit-tam suit a 'witch hunt,' urges pres. of pain drug monitoring firm

Quit-tam suit a 'witch hunt,' urges pres. of pain drug monitoring firm

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A rival's whistleblower lawsuit ostensibly turned on allegations of bad billing but was really a bid to stifle competition, argues Millennium Labs in a motion to dismiss the suit. Millennium president Howard Appel explains why the suit he's contesting is not about reimbursement.

Pain drug monitoring firm enticed docs to use test, qui-tam suit charges

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A national lab promised doctors they could enrich themselves by as much as $2 million a year through a scheme that involved billing payers multiple times for the same urinary drug test, a whistleblower suit alleges.

Roche-sponsored blog pushes HPV test in UK

Roche-sponsored blog pushes HPV test in UK

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Roche, which is launching an HPV test, is sponsoring a blog by a UK healthcare reporter chronicling the process of getting a pap smear.

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MM&M EBOOK: PATIENT ACCESS

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